Preventing Malaria During Pregnancy in Epidemic-Prone Areas.
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Purpose
The purpose of this study is to compare the efficacy and cost-effectiveness of three alternative strategies for the prevention of malaria during pregnancy in an epidemic-prone area of low transmission in the East African Highlands.
The strategies being compared are:
- intermittent preventive treatment with sulfadoxine-pyrimethamine (IPT-SP)
- an insecticide treated net (ITN), and
- intermittent preventive treatment with SP plus an ITN
In addition to the main individually-randomised trial, outcome data was subsequently also gathered on pregnant women whose houses where sprayed with indoor residual insecticides (IRS) as part of a non-randomised district-wide control programme to compare the impact of IRS with the three intervention arms.
| Condition | Intervention | Phase |
|---|---|---|
|
Malaria, Falciparum |
Drug: Intermittent preventive treatment:sulphadoxine-pyrimethamine Device: Insecticide-treated mosquito bed net |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Prevention |
| Official Title: | The Efficacy and Cost-Effectiveness of Malaria Prevention in Pregnancy in an Area of Low and Unstable Transmission in Kabale, Uganda: Use of Intermittent Preventive Treatment and Insecticide-Treated Nets. |
- mean birthweight [ Time Frame: April 2004-Jan 2007 ] [ Designated as safety issue: No ]
- prevalence of low birthweight [ Time Frame: April 2004 - Jan 2007 ] [ Designated as safety issue: No ]
- maternal anaemia - mean Hb at gestational age 36 weeks, prevalence of Hb<100g/L at gestational age 36 weeks [ Time Frame: Feb 2003 - Jan 2007 ] [ Designated as safety issue: No ]
- spontaneous abortions [ Time Frame: Feb 2003 - Jan 2007 ] [ Designated as safety issue: No ]
- stillbirths [ Time Frame: April 2003-Jan 2007 ] [ Designated as safety issue: No ]
| Enrollment: | 4775 |
| Study Start Date: | January 2004 |
| Study Completion Date: | January 2007 |
| Primary Completion Date: | January 2007 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: 1
Drug: Intermittent preventive treatment:sulphadoxine-pyrimethamine
|
Drug: Intermittent preventive treatment:sulphadoxine-pyrimethamine
Two doses given twice during pregnancy (once in the second trimester, and once in the third trimester). Oral medication in tablet form: single daily dose given on each occasion
|
|
Active Comparator: 2
Device: Insecticide-treated mosquito bed net
|
Device: Insecticide-treated mosquito bed net
Insecticide-treated mosquito bed net
|
|
Active Comparator: 3
Combination of Drug + Device: Drug: Intermittent preventive treatment:sulphadoxine-pyrimethamine Device: Insecticide-treated mosquito bed net |
Drug: Intermittent preventive treatment:sulphadoxine-pyrimethamine
Two doses given twice during pregnancy (once in the second trimester, and once in the third trimester). Oral medication in tablet form: single daily dose given on each occasion
Device: Insecticide-treated mosquito bed net
Insecticide-treated mosquito bed net
|
Detailed Description:
Susceptibility to malaria infection during pregnancy and the severity of clinical manifestation are determined by the level of pre-pregnancy immunity, which depends on intensity and stability of malaria transmission. Most intervention trials to prevent malaria during pregnancy have been conducted in areas of intense transmission. The results of trials conducted in high-transmission areas may not be applicable to low transmission areas, where malaria is less frequent but the risk of spontaneous abortion and stillbirth is very high in women of all parities due to lack of sufficient malaria immunity. Routine chemoprophylaxis is generally not recommended in areas of unstable malaria transmission. However, intermittent treatment with an effective anti-malarial drug may be beneficial, especially during periods of malaria transmission. Little work has been carried out amongst pregnant women living in areas of low and unstable transmission in Africa. No data are available on the cost-effectiveness of malaria control in low transmission settings.
This study will compare the efficacy and cost effectiveness of three preventive strategies for the control of malaria during pregnancy in low-transmission settings. The study is located in Kabale district, a highland area in SW Uganda.
Women attending antenatal care are randomised to receive either:
- intermittent preventive treatment with sulfadoxine-pyrimethamine (IPT-SP)
- an insecticide treated net (ITN), or
- intermittent preventive treatment with SP and an ITN. It is hypothesized that when combined with IPT-SP, the additional impact of ITNs by reducing exposure may be greatest where the intensity of transmission is low.
In addition to the main individually-randomised trial, outcome data was subsequently also gathered on pregnant women whose houses where sprayed with indoor residual insecticides (IRS) as part of a non-randomised district-wide control programme to compare the impact of IRS with the three intervention arms.
The study aims to identify the most effective intervention strategies suited to areas characterised by low and unstable transmission. Research findings should be applicable to other hypoendemic areas of the East African highlands.
Eligibility| Ages Eligible for Study: | Child, Adult, Senior |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Pregnant women whose pregnancies are at <27 weeks gestation at first antenatal booking
- Permanent resident in study area
- Informed consent
Exclusion Criteria:
- Late presentation: pregnancies more than 26 weeks gestation at first antenatal booking
- Severe anaemia (Hb<70g/L) on enrolment
- Previous reaction to a sulfa-drug (e.g. sulphadoxine-pyrimethamine, septrin)
- History of severe skin reaction to any drug
- Current (or history) of severe disease (e.g. hepatitis, jaundice, TB, AIDS)
Withdrawal Criteria:
- Withdrawal of consent
- Women developing severe anaemia (Hb<70g/L)during pregnancy
Contacts and LocationsPlease refer to this study by its ClinicalTrials.gov identifier: NCT00142207
| Uganda | |
| Kabale District Health Services (antenatal clinics at selected sites) | |
| Kabale, Kabale District, Uganda | |
| Principal Investigator: | Richard H Ndyomugyenyi, MBChB, PhD | Vector Control Division, Ministry of Health, Uganda |
| Principal Investigator: | Sian E Clarke, PhD | London School of Hygiene and Tropical Medicine, University of London, UK |
| Principal Investigator: | Pascal Magnussen, MD | DBL - Institute for Health Research and Development, Denmark |
| Principal Investigator: | Kristian Schultz Hansen, PhD | DBL - Institute for Health Research and Development, Denmark |
More Information
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| ClinicalTrials.gov Identifier: | NCT00142207 History of Changes |
| Other Study ID Numbers: | ITDCVG32 |
| Study First Received: | August 31, 2005 |
| Last Updated: | February 7, 2008 |
| Health Authority: | Uganda: Ministry of Health |
Keywords provided by Gates Malaria Partnership:
|
malaria pregnancy intermittent preventive treatment insecticide-treated nets |
Additional relevant MeSH terms:
|
Malaria Malaria, Falciparum Protozoan Infections Parasitic Diseases Fanasil, pyrimethamine drug combination Pyrimethamine Sulfadoxine Antimalarials |
Antiprotozoal Agents Antiparasitic Agents Anti-Infective Agents Folic Acid Antagonists Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Anti-Infective Agents, Urinary Renal Agents |
ClinicalTrials.gov processed this record on September 26, 2016